Kornimate/medical-research-clean huggingface dataset:
exploring integrative medicine in swedish primary care

Conditions: Back or Neck Pain of at Least 2 Weeks Duration

Summary: research over the last years have reported an increased popularity of complementary therapies (cts) and an integration of cts into mainstream medical settings, health care organizations and insurance plans. these trends may present both new challenges and new opportunities for health care provision. in sweden and elsewhere, major challenges include the great variety and quality of ct provision within health care and a lack of national and international recommendations of how integrations of cts with conventional care should be modelled, i.e. lack of conceptual models for delivering integrative medicine (im). this may partly be a result of a scarce evidence base in support of im provision within public health care services, e.g. lack of im compared to usual care in randomised clinical trials. it remains largely unknown whether comprehensive models of im are clinically or cost effectively different from conventional care provision. back and neck pain are costly, conventionally managed in primary care and two of the most common conditions treated by cts. we have developed a comprehensive collaborative consensus model for im adapted to swedish primary care. the aim of this pilot study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the im model versus conventional primary care in the management of patients with non-specific back/neck pain.

study objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial.

Eligibility criteria:
inclusion criteria: * back/neck pain with or without headache for at least two weeks and at least three times per week * resident of stockholm county * literate in swedish * willing and able to comply with study requirements exclusion criteria: * specific pathology and severe causes of back/neck pain such as malignant disease, vertebral fractures and severe or progressive neurological symptoms.

Keywords: integrative medicine primary care swedish massage therapy manual therapy naprapathy shiatsu acupuncture qigong pragmatic ranomized controlled pilot trial health services research
oral findings in pediatric patients with allergic rhinitis and/or asthma

Conditions: Allergic Rhinitis; Asthma in Children; Dental Caries; Periodontal Diseases

Summary: the aim of the study was to evaluate if there were differences in oral findings between patients diagnosed with allergic rhinitis and/or asthma and a control group of health people.

the aim of the study was to evaluate if there were differences in oral findings between patients diagnosed with allergic rhinitis and/or asthma and a control group of health people. at the oral evaluation, the following indexes were calculated: psr, periodontal screening and recording; pi, plaque control record and dmft, decayed missing filled teeth index. absence or presence of mouth breathing was also recorded. linear regressions were calculated to compare the oral findings with gravity of allergic rhinitis, to asthma compensation and to asthma treatment.

Eligibility criteria:
inclusion criteria: * age 5-14 years old * presence of allergic rhinitis diagnosed according to asia guidelines and/or presence of asthma diagnosed according to gina guidelines exclusion criteria: * refuse to participate to the study * presence of systemic diseases that could alter oral conditions (sjögren syndrome, celiac disease, calcium disorders).
low dose treosulfan based conditioning regimen and ptcy in hsct for nijmegen breakage syndrome

Conditions: Nijmegen Breakage Syndrome

Summary: the aim of the current study is to evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in hsct with post-transplant cyclophosphamide in nijmegen breakage syndrome

nijmegen breakage syndrome (nbs) is a dna repair disorder. the only curative option for combine immunodeficiency in nbs is allogeneic hematopoietic stem cell transplantation (hsct). standard myeloablative conditioning regimens in dna repair disorders lead to increased morbidity and mortality after hsct. low doses of alkylators are used to reduce toxicity rates, which, however, increase the risks of mixed chimerism and graft failure. the data of treosulfan usage in nbs are sparse. to evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in nbs, treosulfan 21g/m2 in combination with fludarabine 150mg/mg, thymoglobulin (genzyme) 5mg/kg and rituximab 100mg/m2 will be used from day -6 to -1 day, followed by stem cell infusion and post-transplant cyclophosphamide 25mg/kg/day (+3,+4 day) for gvhd prophylaxis. the primary endpoint is event-free survival, where graft failure, death, and malignancies are considered as events.

Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 3 months and \< 21 years 2. patients diagnosed with nbs eligible for an allogeneic hsct 3. signed written informed consent signed by a parent or legal guardian
a phase 1 study of an investigational drug, aln-pcssc, in subjects with elevated low density lipoprotein cholesterol (ldl-c)

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of aln-pcssc in subjects with elevated ldl-c.


Eligibility criteria:
inclusion criteria: * adequate complete blood counts, liver and renal function * female subjects must be of non-childbearing potential; e.g. post-menopausal or pre-menopausal with surgical sterilization * male subjects agree to use appropriate contraception * willing to provide written informed consent and willing to comply with study requirements. * non-smokers and non-nicotine users for at least 90 days before screening * on stable statin co-medication \[for designated multiple dose cohorts only\] exclusion criteria: * any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk * received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study * history of multiple drug allergies or intolerance to subcutaneous injection * received any medication or nutraceutical to alter serum lipids within 30 days before screening (non-statin cohorts only)

Keywords: ldl-c rnai therapeutic
audiovisual interactive games to alleviate pediatric perioperative anxiety

Conditions: Anxiety

Summary: pediatric anxiety upon induction of anesthesia is widely prevalent and can lead to negative patient psychological impact and hindrance to induction of anesthesia. historically, premedication has been used as one means to improve pediatric preoperative anxiety and cooperation with induction. however, giving medication to children prior to surgery has drawbacks. thus, other means have been proposed that may have similar benefits but fewer or different drawbacks. recently, audiovisual distraction in the form of interactive games has been proposed. such games have been in use at children's hospitals around the united states for more than five years. this study is a randomized trial that will explore using interactive games to improve pediatric perioperative anxiety in elective surgery compared with standard-of-care not including games. perioperative anxiety with be evaluated using an observational scale.


Eligibility criteria:
inclusion criteria: * 4 to 14 years of age; * undergoing non-emergent surgery at yale new haven children's hospital requiring general anesthesia; * chooses inhalational induction as induction method; * surgery qualified under one or more of the following fields: otolaryngology, ophthalmology, orthopedics, dentistry, gastrointestinal, general surgery exclusion criteria: * altered mental status; * significant audiovisual deficits (per parent report and at discretion of study team); * received pharmacologic premedication
decision support system for stroke survivors

Conditions: Telerehabilitation; Stroke; Life Style

Summary: the aim of the study is to evaluate the usability of the system and its accordance with the users' needs. this evaluation will consider the effectiveness and the efficiency of the system, as well as stroke survivors' satisfaction. the effectiveness and the efficiency of the system will be measured by: * the relationship between the control of stroke survivors' daily activities and their risk of having a secondary stroke, * the decrease of the need for caregivers, * and consequently an improvement in stroke survivors' self-management.

the aim of the study is to evaluate the usability of the system and its accordance with the users' needs. this evaluation will consider the effectiveness and the efficiency of the system, as well as stroke survivors' satisfaction.

Eligibility criteria:
inclusion criteria: * age 18 to 80 years. * first ischemic stroke within the past 6 months. * hemiparesia with mild (91-99)-moderate (61-90) disability (barthel index). * with or without speech patology but able to understand simple orders ( \>45). * able to cope and to understand the guidelines to use the devices. * informed consent signed. exclusion criteria: * life expectancy \<12 months. * severe cognitive impairments. * medical comorbidities that could interfere with the home-rehabilitation program (moca \< 26). * socio-familiar dystocia (sfes ≥ 14). * modified rankin scale \> 1.
extended rhythm screening for atrial fibrillation in cryptogenic stroke patients

Conditions: Atrial Fibrillation; Stroke

Summary: recent studies demonstrated that prolonged rhythm observation increases the detection of atrial fibrillation in patients prior diagnosed as cryptogenic stroke. detection of atrial fibrillation in these patients has important therapeutic implications for the anticoagulation regimen. however, data on optimal monitoring duration and method of af detection are limited.


Eligibility criteria:
inclusion criteria: * patients \> 18 years of age recent episode (≤60 days) of cryptogenic ischemic stroke * undetermined etiology with negative evaluation (including cardioembolism work- up) according to the criteria for the trial of org 10172 in acute stroke treatment (toast) * implantation of an implantable loop recorder within two months after index event * able of providing informed consent exclusion criteria: * pre-existing indication for vitamin k antagonist * untreated hyperthyroidism * indication for pacemaker implantation, implantable cardioverter defibrillator (icd) or cardiac resynchronisation therapy (crt) * severe co-morbidity not likely to complete follow-up for one year
study of cytokines serum levels in chronic low back pain

Conditions: Interleukines

Summary: the purpose of this study is to: * evaluate if there is an association between elevated levels of cytokines and chronic pain due to herniated disk disease * measured cytokines levels in chronic low back pain and in healthy subjects.

23 patients with at least three months of back pain due to herniated disk disease were selected diagnosis was confirmed by magnetic resonance imaging (mri) or computerized tomography (ct) imaging of the spine for all patients. in addition, pain severity had to be ³ 5 points on the numerical rating scale (nrs) ranging from zero (no pain) to 10 (worst imaginable pain). the exclusion criteria were defined as one or more of the following: psychiatric disorders, systemic or inflammatory disease, history of allergy, presence of motor deficits, history of blood dyscrasia, pregnancy, active infection, tumor, use of analgesic drugs in the week before or inability to come to the hospital for evaluation.

Eligibility criteria:
inclusion criteria: * 23 patients * least three months of back pain due to herniated disk disease * pain severity had to be 5 points on the numerical rating scale (nrs) * 10 healthy volunteers: * without previous history of back pain exclusion criteria: * one or more of the following: * psychiatric disorders * systemic or inflammatory disease * history of allergy * presence of motor deficits * history of blood dyscrasia * pregnancy * active infection, tumor * use of analgesic drugs in the week before * inability to come to the hospital for evaluation.

Keywords: cytokines low back pain intervertebral disk displacement interleukins tumor necrosis factor-alpha
diabetic foot ulcer recurrence: pilot study

Conditions: Diabetic Foot; Ulcer Foot

Summary: in this prospective pilot study, patients with dfu visiting the indiana university comprehensive wound center will be enrolled. patients enrolled in the study will be followed for 16 weeks for wound closure(phase a), and will then begin phase b where tewl measurements and wound recurrence will be followed up for up to 12 weeks.

diabetes impairs immune defenses such that the ability to fight wound infection is weakened. thus, infection is a major problem in diabetic foot ulcers (dfus) . biofilms are estimated to account for 60% of chronic wound infections6. in biofilm bacteria are encased within extra polymeric substance (eps) and become recalcitrant to antimicrobials and host defenses.in the biofilm form, bacteria may not form colony. thus, standard clinical techniques like cfu to detect infection may not detect biofilm infection. thus, biofilm infection may be viewed as a silent threat in wound care. using a preclinical swine model of mixed species wound biofilm infection, we struck an unusual observation. although biofilm infection may or may not influence the rate of wound closure as measured by standard planimetry, it inevitably compromises the functional property of the repaired skin. the wound may close as evaluated visually, but that closed wound lacks barrier function. such pathology is caused by the perturbation of epithelial junctional proteins in response to biofilm infection. while detecting the biofilm directly is readily not possible at present in the wound clinics, compromised barrier function of the repaired skin can be detected at the point of care of the measurement of trans-epidermal water loss (tewl). this pilot study, we propose, many dfus that are currently served with a closed clinical decision may have had a history of biofilm infection and therefore remained functionally open. considering that such incomplete wound closure may have a higher risk of wound recidivism, it becomes critically important that wound closure decisions be guided by functional tests in addition to factors currently considered. importantly, substantial change in health impact may be achieved by a simple functional test as implemented by the measurement of trans epidermal water loss (tewl). tewl can be performed by clinical staff at the point of care within 15 minutes with minimum training using inexpensive hand- held pen like commercial gadgets approved for clinical use.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. willing to comply with protocol instructions, including all study visits and study activities. 3. diabetic foot ulcers 4. adequate arterial blood flow as evidenced by at least one of the following: 1. tcom \> 30 mmhg 2. ankle-brachial index ≥0.7 3. toe pressure \> 30 mmhg exclusion criteria: 1. individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent) 2. wounds closed or to be closed by flap or graft coverage 3. prisoners
1-week dispensing evaluation of kalifilcon a toric contact lenses compared to ultra for astigmatism

Conditions: Myopia; Astigmatism

Summary: experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. all subjects will be seen for a screening/baseline visit at which informed consent will be obtained and eligibility will be assessed.


Eligibility criteria:
inclusion criteria: 1. be 18 years or older on the date the informed consent form (icf) is signed and have the capacity to read, understand and provide written voluntary informed consent. 2. have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. 3. have no active ocular disease or allergic conjunctivitis. 4. not be using any topical ocular medications. 5. be willing and able to follow instructions. 6. have signed a statement of informed consent. exclusion criteria: 1. participating in a conflicting study. 2. considered by the investigator to not be a suitable candidate for participation.
studies of states with resistance to vitamin d and parathyroid hormone

Conditions: Hypocalcemia; Pseudohypoparathyroidism; Osteomalacia; Rickets; Pseudopseudohpoparathyroidism

Summary: patients with confirmed or suspected states with resistance to vitamin d or parathyroid hormone (pth) will be admitted for diagnosis, treatment review with suggestions for modifications to the current or new treatment and for inclusion in other protocols. these states include hypocalcemia, rickets, osteomalacia, pseudohypoparathyroidism. resistance to a factor is manifested by deficient bioeffect despite high levels of the factor in blood. patients will be tested with multiple indices of mineral metabolism to establish the diagnosis and examine the spectrum of the underlying disorder. the principal therapies will be combinations of calcium, phosphate, and a vitamin d analog. selected patients will have localization and surgery to remove a tumor that causes renal wasting of phosphate. patients will also be considered for entry into other research protocols.

patients with confirmed or suspected states with resistance to vitamin d or parathyroid hormone (pth) will be admitted for diagnosis, treatment review with suggestions for modifications to the current or new treatment and for inclusion in other protocols. these states include hypocalcemia, rickets, osteomalacia, pseudohypoparathyroidism. resistance to a factor is manifested by deficient bioeffect despite high levels of the factor in blood. patients will be tested with multiple indices of mineral metabolism to establish the diagnosis and examine the spectrum of the underlying disorder. the principal therapies will be combinations of calcium, phosphate, and a vitamin d analog. selected patients will have localization and surgery to remove a tumor that causes renal wasting of phosphate. patients will also be considered for entry into other research protocols.

Eligibility criteria:
* inclusion criteria: patients, from 2 months to 100 years of age, of either sex m or f, with vitamin d resistance, rickets, osteomalacia, pseudohypoparathyroidism, pseudo-pseudohypoparathyroidism, or suspicion of these or related disorders based upon the appropriateness of their problem to ongoing investigations. current investigations are focused principally upon the inclusion of subjects with, or suspected of having, hypocalcemia likely due to a resistance to parathyroid hormone, including subjects who have a diagnosis, or likely diagnosis, of pseudohypoparathyroidism or pseudopseudohypoparathyroidism.

Keywords: rickets hypocalcemia albright hereditary osteodystrophy pseudohypoaldosteronism natural history
effect of two different fasting blood glucose targets on glucose control in patients with type 2 diabetes using insulin detemir once daily

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america. the aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * 1-3 oral treatments * insulin naive * bmi (body mass index) less than or equal to 45 exclusion criteria: * pregnancy * retinopathy * cardiac disease * uncontrolled hypertension * recurrent hypoglycaemia
study of alvimopan for the management of opioid-induced postoperative bowel dysfunction/postoperative ileus

Conditions: Ileus

Summary: patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (poi), occurring in nearly all cases. signs and symptoms of poi may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and inability to tolerate a solid diet. this study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of gi function in patients having partial small or large bowel resections.

postoperative ileus (poi) can be thought of as temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. patients undergoing major abdominal surgery are at highest risk for developing poi, occurring in nearly all cases. signs and symptoms of poi may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and inability to tolerate a solid diet. this study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of gi function in patients having partial small or large bowel resections.

Eligibility criteria:
inclusion criteria: * subject is scheduled for a partial small/large bowel resection with primary anastomosis; all procedures must be performed completely by open laparotomy. * subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (pca) opioids. exclusion criteria: * subject is scheduled for a total colectomy, colostomy, ileostomy, any laparoscopic or laparoscopically-assisted procedure, or subject has a history of gastrectomy, total colectomy, short bowel syndrome, or multiple previous abdominal surgeries performed by open laparotomy. * subject has complete bowel obstruction. * subject is currently taking opioid analgesics or has taken more than three doses of opioids (oral or parenteral) within the previous 7 days prior to the day of surgery.